- Trial Phase
- Approved (FDA 510(k) cleared, CE Marked)
- Time to Market
- Already on market. Commercially launched in the US in September 2020; CE Mark approval in Europe obtained September 2024.
- Why 4/10
- Auryon is an already-approved, commercially launched medical device with no pending PDUFA or pivotal readout in the next 12 months. The AMBITION BTK randomized trial enrolled its first patient in July 2025 and will not yield a readout for years. There is no hard binary catalyst on the horizon for this product, capping the impact score at 4 per the rubric.
Auryon is the growth engine of AngioDynamics' Med Tech segment transformation, contributing $17.8M in Q4 FY2026 revenue (+14.4% YoY) and delivering 20 consecutive quarters of double-digit growth. The bull case hinges on continued commercial momentum and below-the-knee clinical data expansion; the bear case centers on heavy competition from Medtronic/Philips/Boston Scientific and AngioDynamics' still-modest total revenue (~$320M). With a mean analyst PT of $18 (~44% upside from ~$12.70), the stock already reflects some optimism. Watch quarterly Auryon sales growth rates and AMBITION BTK trial enrollment progress.
Price Chart
Executive Summary
Auryon is a FDA-cleared, commercially launched peripheral atherectomy laser system from AngioDynamics (NASDAQ: ANGO), acquired via the 2019 Eximo Medical purchase for $46M. It uses a proprietary 355-nm solid-state laser to treat peripheral artery disease (PAD) by vaporizing plaque in leg arteries. Auryon has become AngioDynamics' flagship growth product, delivering 20 consecutive quarters of double-digit sales growth and driving the company's Med Tech segment transformation. In Q4 FY2026 (reported July 14, 2026), Auryon generated $17.8M in sales (+14.4% YoY) as part of a $41.8M Med Tech segment. The AMBITION BTK randomized trial for below-the-knee critical limb ischemia began enrollment in July 2025. The company faces stiff competition from Medtronic, Philips, Boston Scientific, and Abbott in the ~$1.1B atherectomy device market. Analyst consensus is heavily bullish (9 buy/strong-buy, 1 hold) with a mean price target of $18, implying ~44% upside.
How It Works
Auryon is a laser catheter device that treats peripheral artery disease (PAD) — blocked arteries in the legs. It delivers short pulses of UV laser light (355-nm wavelength) through a thin fiber-optic catheter threaded into the artery. The laser energy vaporizes plaque (fatty/calcified blockages) without burning the surrounding vessel wall, while a built-in suction system vacuums up debris to prevent particles from traveling downstream. Doctors use it to reopen leg arteries, including in-stent restenosis (blockage inside a previously placed stent).
Trial Status
Auryon has multiple clinical publications supporting its use in peripheral artery disease (PAD). A 12-month prospective multicenter study (Auryon BTK) published July 2025 showed positive outcomes for below-the-knee lesions in chronic limb-threatening ischemia (CLTI). The AMBITION BTK randomized controlled trial (RCT), comparing Auryon + balloon angioplasty vs. angioplasty alone for infrapopliteal lesions in critical limb ischemia, enrolled its first patient in July 2025 and is ongoing.
The Two-Sided Case
Upcoming Catalysts
- Quarterly earnings reports — Auryon sales growth rates are the key metric to watch for sustained Med Tech momentum (next: FY2027 Q1 results expected ~Oct 2026).
- AMBITION BTK trial enrollment updates — any acceleration or expansion of the randomized controlled trial for below-the-knee critical limb ischemia would be positive.
- Potential new catheter/indication 510(k) clearances — Auryon XL radial access catheter (cleared Jan 2024) shows continued product iteration; further platform extensions could expand the addressable market.
- FY2027 guidance — management's outlook for Auryon growth and overall Med Tech segment targets, to be provided with Q4 FY2026 earnings (July 14, 2026) or at investor conferences.
Source Filing
The SecBot filing or press-release report that triggered this drug report:
ANGIODYNAMICS INC 8-K ANGO ·Originating report